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Antimicrobial · FDA Approved

Enfuvirtide (Fuzeon)

FDA-approved

How to ask your doctor
Written by Peptide Association Editorial TeamLast reviewed Editorial policy

01 · Overview

A 36-amino acid synthetic peptide that inhibits HIV-1 entry into CD4+ T-cells by blocking gp41-mediated membrane fusion. Enfuvirtide binds the first heptad repeat region of gp41, preventing the conformational change required for viral-cell fusion.

It was the first FDA-approved HIV fusion inhibitor and was used in patients with virus resistant to other antiretroviral classes (PMID 12637625). The US product Fuzeon is now listed by the FDA as discontinued.

02 · Research summary & key findings

FDA-approved in March 2003 for treatment-experienced HIV-1 patients; the Fuzeon product is now listed as discontinued in the FDA database. In TORO 1, adding enfuvirtide to an optimized background regimen reduced viral load by 1.70 log10 versus 0.76 log10 for the background regimen alone at 24 weeks (PMID 12637625); TORO 2 showed a between-group difference of 0.78 log10 (PMID 12773645). Injection site reactions occurred in 98% of enfuvirtide recipients and led to discontinuation in about 4% over 48 weeks (PMID 16280695). It requires twice-daily subcutaneous injection, which limited its use.

03 · Regulatory status

Enfuvirtide (Fuzeon) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.

Enfuvirtide (Fuzeon) is an FDA-approved medicine prescribed for the conditions on its label. It is not part of our intake, so we do not propose protocols for it. If you think it may be relevant to you, talk to your own doctor. How to ask your doctor.

04 · Administration routes

  • Subcutaneous injection (twice daily)

References

  1. [1]Enfuvirtide, an HIV-1 fusion inhibitor, for drug-resistant HIV infection in North and South America N Engl J Med, 2003. PMID 12637625
  2. [2]Efficacy of enfuvirtide in patients infected with drug-resistant HIV-1 in Europe and Australia N Engl J Med, 2003. PMID 12773645
  3. [3]Safety of enfuvirtide in combination with an optimized background of antiretrovirals in treatment-experienced HIV-1-infected adults over 48 weeks J Acquir Immune Defic Syndr, 2005. PMID 16280695

Primary literature

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Disclaimer: This information is provided for educational and research purposes only. It is not intended as medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before starting any peptide therapy. The Peptide Association does not endorse or recommend any specific treatment protocol. See our editorial policy for how this content is produced and reviewed. Clinicians: join the network.